Webinar On Medical Device Changes and the 510(k)

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Medical Device Changes and the 510(k)
Wednesday, September 22, 2014 1000 AM PDT
0100 PM EDT Duration 90 Minutes Register
Now
This webinar will provide valuable guidance to
regulated companies in development and
implementation of formal, defined, documented
methods for analysis of product changes and when
to file a new 510(k). Consideration of the U.S .
FDAs current K-97-1 Memo or guidance document on
"510(k) Device Modifications"
Instructor
John E. Lincoln
Control of medical device changes and a current
510(k) are big issues in recent FDA studies.
Companies are held fully responsible for deciding
when a new 510(k) filing is warranted. Often this
is a difficult decision process. Effective change
control and the power of current risk management
tools must be a major part of such an analysis.
The U.S. FDA has its current K-97-1 Memorandum
(they recently pulled their proposed new draft
Guidance Document, "510(k) Device
John E. Lincoln is a medical device and
regulatory affairs consultant. He has helped
companies to implement or modify their GMP
systems and procedures, product risk management,
U.S. FDA responses. In addition, he has
successfully
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designed, written and run all types of process,
equipment and software qualifications or
validations, which have passed FDA audit or
submission scrutiny, and described in peer-
reviewed technical articles, and workshops, world
wide. John has also managed pilot production,
regulatory affairs, product development or design
control, 510(k) submissions, risk management per
ISO 14971, and projects with over 28 years of
experience in the FDA-regulated medical products
industry - working with start-ups to Fortune 100
companies, including Abbott Laboratories,
Hospira, Tyco or Mallinckrodt. He is a graduate
of UCLA.
Modifications Deciding When to Submit a 510(k)
for a Change to an Existing Device"). K97-1
provides a tool to assist in device and new
510(k) or change analysis. The addition of such
simple tools will assist companies in
implementing formal, documented, repeatable
methods with defensible rationale for their
decisions on when changes trigger the need for a
new 510(k) submission.
The K97-1 analysis is the preferable tool to work
with a companys change control system to document
the need to file, or the rationale for not
submitting a 510(k). It is recommended as the
preferred method for documentation of each change
in a device during its lifecycle. Provides for a
Step-by-step analysis Manufacturing, Labeling,
Tech or Performance, and or Materials Changes.
Consideration of which of the three major 510(k)
formats should be used Traditional, Special or
Abbreviated.
Areas Covered in the Session This webinar will
provide valuable assistance to all regulated
companies performing and documenting meaningful,
results driven 510(k) or change analysis
activities, based on the FDAs current Guidance on
510(k) Device Modifications. This session will
cover
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companies can best document their decisions --
whether or not a new 510(k) filing is
warranted How to structure a decision matrix to
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Who Will Benefit
This webinar is a must for companies in the
Medical Device and combination products fields.
The employees who will benefit include
Assessing FDAs Proposed Changes to the
510(k) Process
How to Manage a Product Medical Device
Recall Efficiently and Effectively
Research Development Engineering Staff Quality
Assurance Regulatory Affairs Lean Six Sigma
staff New Product Development Marketing Mid-level
and Senior Management Project Leaders Consultants
21 CFR Part 820 - Quality System Regulation -
Applying Principles of Lean Documents and
Lean Configuration
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Format
Design Inputs - Design Outputs Traceability
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